Accurate and timely reporting of adverse events (AEs) in clinical trials is crucial to ensuring data integrity and patient safety. However, AE under-reporting remains a challenge, often highlighted in Good Clinical Practice (GCP) audits and inspections. Traditional detection methods, such as on-site investigator audits via manual source data verification (SDV), have limitations. Addressing this, the open-source R package {simaerep} was developed to facilitate rapid, comprehensive, and near-real-time detection of AE under-reporting at each clinical trial site. This package leverages patient-level AE and visit data for its analyses. The open-source package can be embedded into audits to enable fast, holistic, and repeatable quality oversight of clinical trials. The statistical probability of a site under-reporting adverse events can be used to manage, target and focus quality assurance activities.

 {simaerep} is available publicly on github ( It follows general good practices and standards for R packages and has a high unit test coverage which is tested by an automated pipeline which creates a validation report that is attached to the latest release.

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